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FDA warns of serious genital infection associated with certain diabetes medicines

The US Food and Drug Administration (FDA) announced Wednesday that severe genital infection has been reported in patients who have taken a particular class of diabetes medications.

The alert refers to a class of drugs called SGLT2 inhibitors, first approved in 2013 to lower blood sugar levels in adults with type 2 diabetes.

The US Department of Health has also called for this risk to be included in the labeling of medicines.

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FDA-approved SGLT2 inhibitors include Johnson & Johnson's Invokana, Eli Lilly & Co.'s Jardiance, and Bristol-Myers Squibb, Astra Zeneca Plc, Merck & Co and Pfizer Inc.

Companies have not responded immediately to Reuters request for comment.

Patients are at risk of infection known as Fournier gangrene, an extremely rare, but life-threatening bacterial infection of the tissue under the skin surrounding the genital area, the FDA said in a statement.

The bacteria usually get through a cut in the body and spread quickly. Diabetes is a risk factor for the development of Fournier gangrene.

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The FDA said it identified 12 cases of Fournier gangrene – 7 in men and 5 in women – between March 2013 and May 2018.

One patient died while some required multiple disfiguring surgeries and developed complications, the agency said.

The infection developed within a few months after the patients had received a SGLT2 inhibitor and the drug was stopped in most cases, the FDA said.

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